CLASS II Drug recall · Reported 9 Dec 2015 · FDA Enforcement Report

Tacrolimus 0.03% Opth Oint, Rx recalled by Western Drug

Western Drug is recalling Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, distributed nationwide in the US. The recall was initiated on 19 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall lots

Quantity recalled3 containers

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0479-2016
FDA event ID: 72520
Recalling firm: Western Drug, Springerville, AZ
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2015
FDA classified: 1 Dec 2015
Reported: 9 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility

Timeline

19 Oct 2015	Recall initiated by company
1 Dec 2015	Classified by FDA	+43 days
9 Dec 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Where it was distributed

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

Nationwide Arizona California Georgia New Mexico South Carolina South Dakota Texas Utah

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

all lots

Where was it sold?

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

90 other products · FDA event 72520

This product is part of a recall event; the main page for the event is Hydroxocobalamin 5000IU/mL Injection, Rx recalled by Western Drug.

Reported	Class	Recall	Company	Reason	Where
9 Dec 2015	CLASS II	Hydroxocobalamin 5000IU/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Cantharitus Multi-Mix Prep, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Podophyllum 40% Topical, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Pyridoxine B6 100mg Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Hydroxocobalamin 1mg Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Sermorelin Injection 10mg/,10mg/mL, 20mg/, 9mg/, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Marcaine 0.24%/Ethanol 4% Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Tri-Mix LOW ED Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Calcium Chloride Dihydrate Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Glutathione 300 mg/ Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Dep-Estradiol 10 mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Benadryl 50mg/ Pres-Free Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Furosemide 20 mg/mL svn Sol, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Sal-Acid 60% Plaster Paste, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Tri-Test 1:1:1 300mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Toradol 60mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	PZI 40 Insulin (Human) Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Glutathione 200 mg/mL SVN Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Mupiro/Doxycyc Sinus Rinse, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Sodium Chloride 0.9% Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Super B Complex w/Cyano Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Tev-Tropin (Somatropin) Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Alcohol4%/Bupivicaine0.5% sol, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Ace-Promazine 10 mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Heparin/mL Injection, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Ascorbic Acid 500 mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Sodium Bicarbonate 8.4% Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Lidocaine Injection 1% , 2%, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Quad Mix Strong Inj, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	17-Hydroxyprogesterone 250mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Dexpanthanol B5 250mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Sodium Hydroxide 10% Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Phenylephrine 500mcg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Jessners Dermal Solution, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	HCG 10,000U/ Injection, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Hydroxocobalamin 1mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Depo-Testadiol 10/5mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Triamcin40/Lido5 mg/mL Sus, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Magnesium Sulfate 50% Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Vitamin B-Complex 100 Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Cantharidin 0.7% Sol, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Cyclosporine 1% Opth Sol, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Calcium EDTA 300mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	AMP50/B121MG Complex Mix/ML Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Folic Acid Injection 5 mg/mL,10 mg/mL, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Magnesium Chloride Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	M-Cobalamin 2/Folate 5mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	B-12 1000/B6 1000 mcg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Verapamil 120mg/ Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Tacrolimus 0.02% Opth Sol, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Super B Comp w/Cyano 3X Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Calcium Gluconate 10% Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Wilson's Nasal Irrigation Solution, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Hydrochloric Acid 2mg Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Omnitrope 17.4U/ Inj-Kit, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	HCG MTU vial, Rx, Western Drug Inc. 106 E. Main Street recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Novarel "HCG" 10000U/Vial, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Lipodissolve 100/50mg Inj Sol, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Heparin Sodium 30,000U/ Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	VitB12/VitC/VitB3/VitB9 Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Butor/Nal/Hydro Nasal Susp, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Tri-Amino OAC 1:1:1 300mg/mL, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Cyancobalamin 2000mcg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Ketorolac 40mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Procaine HCl Injection 1%, 2%, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Testost CYP 200mg/mL SUS, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Potassium Chloride 40 mEq/mL Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	Testosterone CYP Inj 200 mg/mL, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015	CLASS II	T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide

More recalls from Western Drug

All 91

Reported	Class	Recall	Company	Reason	Where
9 Dec 2015Drug	CLASS II	T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main recalled	Western Drug	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Testosterone CYP Inj 200 mg/mL, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Potassium Chloride 40 mEq/mL Inj, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Testost CYP 200mg/mL SUS, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
9 Dec 2015Drug	CLASS II	Procaine HCl Injection 1%, 2%, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide